Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• Subject must be 18 years of age or older at the time the Informed Consent is signed

• The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial

• Pathologic diagnosis of prostate cancer of adenocarcinoma histology; presence small cell/neuroendocrine carcinoma is exclusionary

• Metastatic disease as documented by:

‣ Osseous metastases detected by technetium-99m (99mTc) planar bone scan or NaF PET scan, or CT scan at some point in patient's history

⁃ Soft tissue metastases documented on CT or MRI

• PSMA avid metastatic disease as determined by 18F-DCFPyL: at least one lesion with PSMA avidity greater than that of liver (see Prescribing Information for Pluvicto)

• Progressive castration resistant prostate cancer as defined by serum testosterone \< 50 ng/mL and one of the following:

‣ PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3)

⁃ Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3

• Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide

∙ NOTE: These AR signaling inhibitors may have been used for mCSPC, M0CRPC, and/or mCRPC.

• ECOG PS grade of 0-2

• 10 metastases detectable on molecular imaging (PSMA and FDG PET) and amenable to SBRT

‣ 20% of metastases that are FDG avid but PSMA negative

⁃ Metastases that are not detectable on PSMA and FDG PET do not count toward the total number of metastases, as they are presumed to represent adequately treated sites of disease

• Life expectancy 6 months

• Adequate organ function:

‣ Hemoglobin (hgb) \> 8.0 g/dL

⁃ Absolute neutrophil count (ANC) \> 1500/ µL

⁃ Platelets \> 75,000/ µL

⁃ Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels \>1.5 x ULN

⁃ ALT and AST 3.0 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded)

⁃ Creatinine \< (2.0 mg/dL) during screening evaluation (\>2.0 is allowed if EGFR \>30 mL/min/1.73 m2)

• Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period

Locations
United States
California
VA Long Beach Healthcare System, Long Beach, CA
NOT_YET_RECRUITING
Long Beach
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
NOT_YET_RECRUITING
Hines
Contact Information
Primary
Nicholas G Nickols, MD PhD
nicholas.nickols@va.gov
(310) 478-3711
Backup
Matthew B Rettig, MD
matthew.rettig@va.gov
(310) 478-3711
Time Frame
Start Date: 2023-12-14
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Arm 1
Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration
Experimental: Arm 2
Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration, followed by restoration of physiologic testosterone
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov